Modra’s boosted oral formulation of docetaxel, ModraDoc006/r, was designed to address limitations associated with IV-administered docetaxel.

Docetaxel, a member of the taxane class of anti-cancer therapies, is one of the most frequently used chemotherapy drugs globally and is part of standard regimens for several major solid tumor types, including prostate, breast, head and neck and lung cancer. In common with other taxanes, docetaxel is effective but hampered by a burdensome hospital-based IV administration process, as well as extensive side-effects. Although part of docetaxel’s toxicity is related to its mode of action, some key toxicities (including neutropenia) are exacerbated by its pharmacokinetics, most notably the high initial blood concentration caused by intravenous (IV) administration. In addition, key excipients used in its IV formulation, including polysorbate 80 and ethanol, are known to cause significant additional side effects.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells. IV docetaxel is currently the dominant form of chemotherapy used in mCRPC patients, and is typically used in a first-line setting in chemotherapy-naïve patients.

Modra has recently completed a Phase IIb clinical trial of ModraDoc006/r in patients with mCRPC, the results of which were presented at ASCO in June 2022, and the company is in the planning stages for a phase III study.

Modra’s oral formulation of paclitaxel, ModraPac005/r, has been studied in an initial Phase I clinical study. Paclitaxel, a member of the taxane class of anti-cancer therapies, is one of the most frequently applied chemotherapy drugs globally and shares a similar efficacy and toxicity profile with docetaxel.